MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1008K

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the luer connector of a large volume infusor was blocked during the exhaust, and the pressure exhaust method of the three-way pipe had no effect.The issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured on november 30, 2021 - december 1, 2021.H10: the actual device was not available; however, two (2) photographs of the sample were provided for evaluation.A visual inspection was performed to the photographs, using the naked eye, which revealed that the first photo showed the device lot number and the second photo showed a deflated bladder from an infusor device.Due to the nature of the sample, no additional tests could be performed the reported condition was not verified by evaluation of the photographs.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17396831
• MDR Text Key: 319807316
• Report Number: 1416980-2023-03779
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022512
• UDI-Public: (01)00085412022512
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C1008K
• Device Lot Number: 21M024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1